D2L-SMO offers site management services for phase II - IV clinical studies across a wide range of therapeutic areas  to sponsors having a progressive drug development agenda, so that they can leverage the facilities available in India to achieve their goals in a cost effective and efficient manner.

D2L-SMO has also developed strengths in Bioequivalence Studies in Oncology. These studies are done on Oncology subjects in hospital setup. We have fortified our presence in the field of Oncology by building a strong network of oncologists, with a pan-India presence. Our rich expertise and experience in this field is complemented with our network of ICH-GCP compliant sites.

Our range of services for pharmaceutical companies is the following:

Feasibility Assessment
An accurate and realistic feasibility assessment plays a vital role in identifying and assessing status of the clinical study. We provide assistance in deciding whether to proceed with, alter, or drop a particular project or plan of action.
We have an intimate knowledge of the strengths and weaknesses of the clinical trial process within each site and are well placed to make thorough assessments of the suitability for a particular study. We respond within a week of conducting the assessment. The outstanding results help us in creating trust and confidence within our clients. Give us the opportunity to work for you; we will let you know the challenges, trends and issues to save your time, money and stress.

• Investigator Identification: We can quickly shortlist investigators across a range of parameters including investigator qualification, specializations, clinical trial experience, recruitment records and thus help in placing your study in experienced hands.
• Site Identification: For successful implementation of trial studies it is important to identify proper sites and we help pharmaceutical companies in the identification of potential, ICH-GCP compliant sites

At D2L, we offer free feasibility assessment. To request your feasibility assessment, click here

Site Preparation and Up gradation:Our perpetual efforts to upgrade infrastructure at sites is in accordance with the protocol specific requirement making sure they qualify for participating in the trial.

IRB / IEC Submissions
We understand the ethics and regulatory environment in India better with our rich experience in handling large number of studies across various centres in India. We work closely with Investigators ensuring one time submission & approval with all subsequent amendments are conveyed and favourable approval obtained. All safety events are reported within the specified timelines with timely reporting on the progress of the study.

Patient Recruitment Using Our Unique FEP Method
When your clinical trial is delayed by slow subject enrollment, you need to quickly identify the issues impacting patient recruitment to find the best solutions. We are dedicated to provide you with excellence in patient recruitment strategies and services to improve outcomes - regardless of the clinical trial obstacles you face.

Documentation with Electronic Data Capture (EDC) expertise
We place a full-time, highly qualified clinical research coordinator at each study site to assist the investigators and site staffs with all day-to-day study conduct activities. Our coordinators are trained to provide professional support to the investigator ensuring compliance with FDA, local regulatory and ICH-GCP guidelines and efficient completion of assigned duties. The study coordinators are experienced in Electronic Data Capture (EDC) based trials. This helps in accurate data entry and thereby reducing queries from data management departments. Our Project Management and Quality Management Team carry out constant internal monitoring at the various sites to facilitate the documentation efficiently. This ensures collection of high quality study data necessary for regulatory and product approval submissions.

Monitoring
We have an extended monitoring service that ensures perfect functioning. Our dedicated Monitors visit different hospitals to find out the status of the project. This includes assessing the documentation work, infrastructure setups, patient recruitment status & efforts, functioning, and other aspects of project.

Training
Our HR policy addresses the need to retain the talent and our training program improves the standards of our employees and the investigators. We put strong emphasis on continuous professional development and to that end in-service training across all sites is mandatory for employees. All sites are trained in and adhere to the Standard Operating Procedures (SOPs), D2L-SMO SOPs also cover patient recruitment and retention. To ensure that clinical research is conducted to the highest possible standards, all are trained on Good Clinical Practices (GCP) before conducting their first study at our site.

Consulting & Regulatory Support Services
Our understanding of regulatory environment and experienced personnel, places us at a competitive position to serve our clients better. We are well known with the ethics and regulatory requirements since we have done large number of studies.  We prepare the regulatory package which includes: Investigator CVs, Financial Disclosure Forms (FDFs), Investigator Undertakings, FDA Form1572, IRB Forms, Informed Consent Templates, and Site Contact Information Forms.  Regulatory package will then be submitted to the sponsor. The entire process is completed quickly so that rapid review can be done.

Staffing Services
We provide skilled and well experienced human resources to the pharmaceutical companies so that highest possible standards can be maintained. Our project members works for the pharmaceutical companies at daily or monthly basis.